Comprehensive Genomic Analysis in Tissue Samples From Patients With Recurrent or Stage IV Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT02178163|
Recruitment Status : Recruiting
First Posted : June 30, 2014
Last Update Posted : September 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer||Other: cytology specimen collection procedure Other: laboratory biomarker analysis||Not Applicable|
I. To assess the percentage of advanced non-small cell lung cancer patients in whom therapy can be initiated based on genomic analysis of tumor specimens.
I. To estimate the percentage of patients in whom genomic analysis can be performed.
II. To assess the progression free survival and response rate in patients who start therapy based on the genomic analyses results.
Patients undergo collection of tissue samples for genomic analysis via mass spectrometry, polymerase chain reaction (PCR), and microarray. Based on the results of the genomic analysis, patients may begin therapy.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then every 12 months thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This study will assess the percentage of advanced NSCLC patients whose tumor samples can undergo genomic analysis and in whom therapy can begin based on the results of this analysis.|
|Masking:||None (Open Label)|
|Official Title:||A Study to Assess the Ability to Initiate Therapy in Advanced Non-small Cell Lung Cancer (NSCLC) Patients Based on Genomic Analyses of Tumor Specimens.|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||March 2022|
Experimental: Ancillary-Correlative (comprehensive genomic analysis)
Patients undergo collection of tissue samples for genomic analysis via mass spectrometry, PCR, and microarray. Based on the results of the genomic analysis, patients may begin therapy.
Other: cytology specimen collection procedure
Other Name: cytologic sampling
Other: laboratory biomarker analysis
- Proportion of patients receiving therapy based on genomic analyses among all eligible patients [ Time Frame: Up to 21 days ]Will be estimated with 95% confidence interval (CI) using the Wilson's method.
- Overall response rate assessed according to Response Evaluation Criteria in Solid Tumors 1.1 [ Time Frame: Up to 2 years ]Response rate will be estimated with 95% Wilson's CI.
- Progression free survival (PFS) [ Time Frame: Time from the date of start of therapy based on genomic analysis until the date that progressive disease or death whichever is first reported, assessed up to 2 years ]PFS will be estimated and may also be summarized within subgroups using descriptive statistics (Kaplan and Meier) if there are sufficient data.
- Overall survival (OS) [ Time Frame: From date of registration to up to 2 years ]Not all patients enrolled on the study will receive therapy based on genomic analyses therefore survival will be analyzed for patients who receive therapy based on genomic analyses, for patients who don't receive therapy based on genomic analyses and for the entire patient population. OS will be estimated and may also be summarized within subgroups using descriptive statistics (Kaplan and Meier) if there are sufficient data.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02178163
|Contact: Gerold Bepler, M.D.||(313) 576-8665|
|United States, Michigan|
|KCI at McLaren Bay Region||Recruiting|
|Bay City, Michigan, United States, 48708|
|Barbara Ann Karmanos Cancer Institute||Recruiting|
|Detroit, Michigan, United States, 48201|
|Contact: Gerold Bepler, M.D. 800-527-6266 firstname.lastname@example.org|
|Sub-Investigator: Amy Weise, D.O.|
|Principal Investigator: Gerold Bepler, M.D., PhD.|
|Sub-Investigator: Ammar Sukari, M.D.|
|Sub-Investigator: Antoinette Wozniak, M.D.|
|Sub-Investigator: Hirva Mamdani, M.D.|
|Sub-Investigator: Misako Nagasaka, M.D.|
|Sub-Investigator: Alicia Bolling-Fischer, M.D.|
|Sub-Investigator: Susan Land, M.D.|
|Sub-Investigator: Fulvio Lonardo, M.D.|
|Sub-Investigator: David Cook, M.D.|
|Sub-Investigator: Jonathan D. Abramson, M.D.|
|Sub-Investigator: Shalini Thoutreddy, M.D.|
|Sub-Investigator: Sharon Levandowski, M.D.|
|Sub-Investigator: Youssef Hanna, M.D.|
|Sub-Investigator: Samir Alsawah, M.D.|
|Sub-Investigator: Faheem Ahmad, M.D.|
|Sub-Investigator: Maden Arora, M.D.|
|Sub-Investigator: Sai Bikkina, M.D.|
|Sub-Investigator: Rana Bilbeisi, M.D,|
|Sub-Investigator: Aliccia Bollig-Fischer, M.D.|
|Sub-Investigator: Irene Connolly, M.D|
|Sub-Investigator: Elena Coppola, M.D.|
|Sub-Investigator: David Eilender, M.D.|
|Sub-Investigator: Salman Fateh, M.D.|
|Sub-Investigator: Lisa Galloway, M.D.|
|Sub-Investigator: Sandeep Grewa, M.D.|
|Sub-Investigator: Christian Hyde, M.D.|
|Sub-Investigator: Ronald Kawauchi, M.D.|
|Sub-Investigator: Frank Knechtl, M.D.|
|Sub-Investigator: Cheryl Kovalski, M.D.|
|Sub-Investigator: Elizabeth Layhe, M.D.|
|Sub-Investigator: Stephanie Leslie, M.D.|
|Sub-Investigator: Tallat Mahmood, M.D.|
|Sub-Investigator: Mohammed Masri, M.D.|
|Sub-Investigator: Seraphim Pallas, M.D.|
|Sub-Investigator: Paul Porter, M.D.|
|Sub-Investigator: Somdev Roy, M.D.|
|Sub-Investigator: Trevor Singh, M.D.|
|Sub-Investigator: Anteneh Tesfaye, M.D.|
|KCI at McLaren Port Huron||Recruiting|
|Port Huron, Michigan, United States, 48060|
|Principal Investigator:||Gerold Bepler, M.D.||Barbara Ann Karmanos Cancer Institute|